Medroxyprogesterone
MedroxyPROGESTERone Acetate Tablets USP
Approved
Approval ID
1403a9a9-c04a-432f-8819-4850f779312e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 9, 2022
Manufacturers
FDA
PharmPak, Inc.
DUNS: 175493840
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MEDROXYPROGESTERONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54348-805
Application NumberANDA040159
Product Classification
M
Marketing Category
C73584
G
Generic Name
MEDROXYPROGESTERONE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2022
FDA Product Classification
INGREDIENTS (7)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
METHYLCELLULOSE (15 CPS)Inactive
Code: NPU9M2E6L8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MEDROXYPROGESTERONE ACETATEActive
Quantity: 10 mg in 1 1
Code: C2QI4IOI2G
Classification: ACTIB